Cytodyme

An AI-enabled SaaS platform for post-market quality and regulatory workflows that automates complaint intake, investigations, vigilance, literature surveillance, and generation of audit-ready reports including PSUR, PMPF, CER, and MDR/IVDR and FDA filings. It sells to quality, regulatory, and operations teams at medical device and life sciences companies ranging from early-stage to enterprise. It is delivered as a FDA 21 CFR Part 11 compliant SaaS with end-to-end audit trails and connected data that replaces disconnected files and repetitive manual reporting with automation.

Key features

• Complaint management and intake
• Automated severity and risk assessment
• Reportability decision documentation
• Post-market reporting generation (PSUR, PMPF, CER)
• MDR, IVDR and FDA report drafting
• Literature surveillance and screening
• Validated literature searches
• Audit-ready evidence outputs
• End-to-end audit trails
• FDA 21 CFR Part 11 compliance
• MDR & IVDR workflow support
• Trend tracking across products and regions
• UDI, lot and serial tracking
• Regulatory update monitoring
• Traceable change and approval records